TY - JOUR
T1 - Postauthorization Changes to Specific Obligations of Conditionally Authorized Medicines in the European Union
T2 - A Retrospective Cohort Study
AU - Bloem, Lourens T
AU - Mantel-Teeuwisse, Aukje K
AU - Leufkens, Hubert G M
AU - De Bruin, Marie L
AU - Klungel, Olaf H
AU - Hoekman, Jarno
N1 - © 2018 American Society for Clinical Pharmacology and Therapeutics.
PY - 2019/2
Y1 - 2019/2
N2 - When medicines are granted a Conditional Marketing Authorisation (CMA) in Europe, specific obligations are requested to obtain comprehensive data on benefits and risks. We performed a retrospective cohort study to characterize obligations, examine changes to their description and due dates after initial authorization, determine timing of data submission relative to due dates, and identify drug-related, procedure-related, and obligation-related factors associated with change. We identified 69 obligations for 26 medicines conditionally authorized between 2006 and 2016. We found 39 changes to 27 obligations (39% of obligations), of which four substantially changed the obligation. For 55% of obligations, data submission was delayed. Eleven factors were associated with change, including the use of CMA as a rescue option. The results are potentially indicative of a continuous search by regulators to reduce uncertainties. Submission delays impact public health negatively by prolonging exposure of patients to unknown risks, particularly when the level of uncertainty is high.
AB - When medicines are granted a Conditional Marketing Authorisation (CMA) in Europe, specific obligations are requested to obtain comprehensive data on benefits and risks. We performed a retrospective cohort study to characterize obligations, examine changes to their description and due dates after initial authorization, determine timing of data submission relative to due dates, and identify drug-related, procedure-related, and obligation-related factors associated with change. We identified 69 obligations for 26 medicines conditionally authorized between 2006 and 2016. We found 39 changes to 27 obligations (39% of obligations), of which four substantially changed the obligation. For 55% of obligations, data submission was delayed. Eleven factors were associated with change, including the use of CMA as a rescue option. The results are potentially indicative of a continuous search by regulators to reduce uncertainties. Submission delays impact public health negatively by prolonging exposure of patients to unknown risks, particularly when the level of uncertainty is high.
U2 - 10.1002/cpt.1169
DO - 10.1002/cpt.1169
M3 - Journal article
C2 - 29969839
SN - 0009-9236
VL - 105
SP - 426
EP - 435
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 2
ER -